Device product
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
Z-1834-2020
Product summary
- Event
- Event 85298
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3181
- Official record key
device-enforcement:Z-1834-2020
Official wording
Reason: The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.
Code information: UDI: 10758750005147; Lot Number: 2340
Distribution pattern: US Nationwide. Australia, Bermuda, Belgium, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, UK.
Derived failure modes
-
Unknown
The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.